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Biogen to Participate in the Jefferies Global Healthcare Conference

On November 10, 2026 Biogen Inc. (Nasdaq: BIIB) reported that Alisha Alaimo, President, Head of North America, will participate in a fireside chat during the Jefferies Global Healthcare Conference in London. The webcast will be live on Tuesday, Nov 17, 2026, at 1:30pm GMT / 8:30 a.m. EST. To access the live webcast, please visit the Investors section of Biogen’s website at investors.biogen.com. An archived version of the webcast will be available for at least 30 days following the presentation.

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(Press release, Biogen, NOV 10, 2026, View Source [SID1234674581])

Ascendis Pharma to Participate in the Jefferies London Healthcare Conference

On November 10, 2026 Ascendis Pharma A/S (Nasdaq: ASND) reported that company executives will participate in a fireside chat at the Jefferies London Healthcare Conference on Tuesday, November 17, 2026, at 11:30 a.m. Greenwich Mean Time (GMT) / 6:30 a.m. Eastern Time / 3:30 a.m. Pacific Time in London, United Kingdom.

A live webcast of the presentation will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.

(Press release, Ascendis Pharma, NOV 10, 2026, View Source [SID1234674580])

AbelZeta Receives FDA RMAT and Fast Track Designations for Prizlon-cel in Relapsed or Refractory Large B-Cell Lymphoma

On November 10, 2026 AbelZeta Inc. ("AbelZeta" or the "Company"), a cell therapy leader focused on discovering, developing and manufacturing therapeutics to address unmet medical needs in oncology and inflammatory and immunological diseases, reported that the U.S. Food and Drug Administration (FDA) has granted both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations to Prizloncabtagene Autoleucel (Prizlon-cel), also known as A-CAR039, an investigational anti-CD20/CD19 bispecific CAR-T therapy for the treatment of patients with relapsed or refractory (r/r) large B-cell lymphoma (LBCL).

The designations were granted under AbelZeta’s Investigational New Drug (IND) application (STN 32908) and support the Company’s continued U.S. development of Prizlon-cel in r/r LBCL.

AbelZeta is pursuing a development strategy spanning both later-line patients previously treated with FDA-approved CAR T-cell therapies and patients treated earlier in the course of disease.

As part of the strategy, AbelZeta plans to evaluate Prizlon-cel in ABZT-121 (NCT07875413), a Phase 2 study in patients with r/r LBCL following treatment with an FDA-approved, commercially available CAR T-cell therapy. AbelZeta intends to evaluate whether results from ABZT-121 could support a potential accelerated-approval pathway in this population, subject to clinical results and future discussions with FDA. In parallel, the Company is developing ABZT-131, a randomized clinical study of Prizlon-cel in the second-line treatment of r/r LBCL. The study is intended to evaluate Prizlon-cel earlier in the treatment course and to further define its potential role relative to established CAR T-cell therapies. Together, ABZT-121 and ABZT-131 are intended to support a broader development strategy for Prizlon-cel across clinically important r/r LBCL treatment settings.

RMAT designation provides opportunities for intensive FDA interaction regarding clinical development, including discussions intended to support efficient development and potential approval. Fast Track designation is intended to facilitate development and expedite review of therapies for serious conditions with unmet medical need and may provide opportunities for more frequent FDA interactions and rolling review of portions of a future Biologics License Application (BLA), if applicable requirements are met.

"These dual FDA designations are important milestones for Prizlon-cel and support our strategy to develop it across multiple treatment settings in r/r LBCL," said Tony Liu, Chief Executive Officer of AbelZeta. "Our near-term development strategy includes patients whose disease has progressed following prior CAR T-cell therapy, a population with substantial unmet medical need, while we are also preparing to evaluate Prizlon-cel earlier in the treatment course through a randomized second-line program. We look forward to working closely with the FDA as we advance both elements of this development strategy."

In July 2026, AbelZeta regained all global development, regulatory, manufacturing, commercialization and other collaboration rights relating to Prizlon-cel. In August 2026, the Company received FDA clearance of its IND application (STN 32908) to advance the U.S. clinical development of Prizlon-cel in r/r LBCL.

(Press release, AbelZeta, NOV 10, 2026, View Source [SID1234674577])

Xilio Therapeutics Reports Third Quarter 2026 Financial Results and Provides Pipeline and Business Updates

On November 10, 2026 Xilio Therapeutics, Inc. (Nasdaq: XLO), a clinical-stage biotechnology company discovering and developing masked immuno-oncology therapies for people living with cancer, reported pipeline progress and business updates and reported financial results for the third quarter ended September 30, 2026.

"In the third quarter, we initiated our Phase 1/2 clinical trial for XTX501, a PD-1/masked IL-2 bispecific that we believe has the potential to become a foundational backbone immunotherapy regimen for solid tumors," said René Russo, Pharm.D., president and chief executive officer of Xilio. "By incorporating masking and tumor-selective activation of a high potency, alpha-optimized IL-2 with inhibition of PD-1/PD-L1 in a single molecule, XTX501 is designed to simultaneously leverage these two validated mechanisms, while overcoming the toxicity and rapid clearance that have limited non-masked IL-2 therapies. We also continued to execute across our preclinical pipeline, advancing our programs for masked, multi-specific TCEs with built-in co-stimulation toward planned IND filings next year."

Pipeline Progress and Business Updates

XTX501: PD-1/masked IL-2 bispecific

XTX501 is a novel, investigational PD-1/masked IL-2 (alpha-optimized) bispecific antibody fusion protein that combines two complementary mechanisms in a single molecule: selective inhibition of the PD-1/PD-L1 pathway and potent IL-2-driven expansion of T cells. The PD-1 binding arm is designed to selectively direct IL-2 activity to PD-1 positive, antigen-experienced T cells and enhance their function. The IL-2 binding arm incorporates a masked, high potency IL-2 variant with an alpha-optimized receptor binding profile. By leveraging Xilio’s proprietary masking technology, XTX501 aims to overcome IL-2 receptor-mediated clearance, peripheral activity and tolerability challenges associated with non-masked IL-2 therapies.

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Xilio recently dosed the first patient in the Phase 1 portion of the trial for XTX501 in patients with metastatic non-small cell lung cancer (NSCLC) and select advanced solid tumors. For more information, read the press release here.
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Xilio recently presented a trial-in-progress poster highlighting the design of the Phase 1/2 clinical trial of XTX501 at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 41st Annual Meeting.
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Xilio plans to report initial Phase 1 data in patients with metastatic NSCLC in the fourth quarter of 2027.

Masked T Cell Engager (TCE) Programs

As part of the core design, Xilio’s TCEs incorporate a masked CD3 binding domain, a tumor-associated antigen (TAA) binding domain and built-in co-stimulation. The company’s modular architecture enables the flexibility to incorporate additional TAA binding domains and mask the TAA binding domain(s) and/or co-stimulatory signaling domain. Upon tumor-selective activation, the molecules are designed to release the mask(s) and deliver a potent TCE with a short half-life in the tumor microenvironment.

XTX602: dual-masked CLDN18.2-targeting multi-specific TCE with co-stimulation

XTX602 is a potential first-in-class, dual-masked CLDN18.2-targeting multi-specific TCE with built-in CD2 co-stimulation. CLDN18.2 is a TAA expressed in gastrointestinal cancers (gastric, pancreatic and esophageal). By incorporating masks for both the CLDN18.2 and the CD3 binding domains, XTX602 is designed to overcome potential gastrointestinal toxicity associated with non-masked CLDN18.2-targeting molecules. In addition, the CD2 co-stimulatory domain is built directly into the molecule to enable enhanced T cell activation, expansion and durability of T cell response.

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Investigational new drug application (IND)-enabling studies for XTX602 are ongoing, and Xilio plans to submit an IND for XTX602 in the fourth quarter of 2027.

XTX701: masked PSMAxSTEAP1-targeting multi-specific TCE with co-stimulation

XTX701 is a potential first-in-class, masked PSMAxSTEAP1-targeting multi-specific TCE with built-in CD2 co-stimulation. PSMA and STEAP1 are TAAs collectively expressed in approximately 95% of metastatic castration-resistant prostate cancer. Targeting these two TAAs is intended to address heterogeneity of expression of PSMA and STEAP1 across prostate tumors and limit resistance and lack of durability of response due to antigen escape. By incorporating a mask for the CD3 binding domain, XTX701 is designed to minimize toxicity due to peripheral T cell activation and on-target, off-tumor engagement associated with non-masked molecules. In addition, the CD2 co-stimulatory domain is built directly into the molecule to enable enhanced T cell activation, expansion and durability of T cell response.

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IND-enabling studies for XTX701 are ongoing, and Xilio plans to submit an IND for XTX701 in the fourth quarter of 2027.

Efarindodekin alfa: masked IL-12

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Xilio is evaluating efarindodekin alfa as a monotherapy in an ongoing Phase 2 clinical trial in patients with advanced solid tumors and expects to deliver an option data package to Gilead Sciences, Inc. (Gilead) in the first half of 2027.

Recent Corporate Updates

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Xilio appointed Yariv Houvras, M.D., Ph.D., as its chief medical officer in September 2026. Dr. Houvras has over 20 years of executive leadership across premier industry and academic research institutions in clinical development, translational medicine and immuno-oncology. Read more here.

Third Quarter 2026 Financial Results

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Cash Position: Cash and cash equivalents were $122.2 million as of September 30, 2026, compared to $137.5 million as of December 31, 2025.
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Collaboration and License Revenue: Collaboration and license revenue was $10.0 million for the quarter ended September 30, 2026, compared to $19.1 million for the quarter ended September 30,

Xilio is leveraging its proprietary, clinically-validated masking technology and modular TCE architecture to advance two wholly-owned masked TCE programs, as well as an additional masked TCE program in collaboration with AbbVie Group Holdings Limited (AbbVie).

2025. The decrease was driven by a decrease in collaboration and license revenue recognized under the company’s collaboration and license agreements with AbbVie and Gilead.
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Research & Development (R&D) Expenses: R&D expenses were $14.8 million for the quarter ended September 30, 2026, compared to $14.3 million for the quarter ended September 30, 2025. The increase was primarily driven by an increase in preclinical research and development activities related to the company’s wholly-owned masked TCE programs, an increase in clinical trial startup activities related to the company’s Phase 1/2 clinical trial for XTX501 and an increase in personnel-related costs due to higher research and development headcount, partially offset by a decrease in preclinical development activities and manufacturing activities related to IND-enabling studies for XTX501 and a decrease in clinical development activities for efarindodekin alfa and vilastobart.
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General & Administrative (G&A) Expenses: G&A expenses were $6.9 million for the quarter ended September 30, 2026, compared to $6.7 million for the quarter ended September 30, 2025. The increase was primarily driven by an increase in stock-based compensation expense.
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Net Loss: Net loss was $5.9 million for the quarter ended September 30, 2026, compared to a net loss of $16.3 million for the quarter ended September 30, 2025.

Cash Runway

Based on its current operating plans, Xilio anticipates that its existing cash and cash equivalents will be sufficient to enable it to fund its operating expenses and capital expenditure requirements into the first quarter of 2028.

This estimate excludes up to $36.2 million in additional gross proceeds in the fourth quarter of 2026 if all outstanding Series C warrants are exercised at their current exercise price and any potential additional milestone payments, option-related fees or other contingent payments under Xilio’s collaboration and license agreements with AbbVie and Gilead, including up to $31.0 million in near-term milestones and option extension fees that could be achieved under the AbbVie collaboration through the first half of 2027.

(Press release, Xilio Therapeutics, NOV 10, 2026, View Source [SID1234674572])

Tyra Biosciences Reports Third Quarter 2026 Financial Results and Recent Highlights

On November 10, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported financial results for the third quarter ended September 30, 2026, and highlighted recent corporate progress.

"2026 has been a defining year for TYRA. With the initial results from SURF302 in the ablative setting, we believe dabogratinib has the potential to be the first oral FGFR3-selective inhibitor in intermediate-risk non-muscle invasive bladder cancer (IR NMIBC), reinforcing our conviction in the potential of precision FGFR3 inhibition to fundamentally change the treatment paradigm for patients," said Todd Harris, PhD, President and Chief Executive Officer of TYRA. "For too long, patients have faced a cycle of repeated procedures and surveillance, often simply waiting for their cancer to recur. We believe dabogratinib has the potential to break this cycle by offering a differentiated, first-in-class oral product candidate that could transform how patients and physicians manage this chronic, recurrent disease."

Dr. Harris continued, "With a strengthened balance sheet following our $400 million financing, TYRA is entering its next phase of growth from a position of strength. We now have the financial resources to advance our dabogratinib 3×3 strategy through late-stage clinical development. As we prepare for regulatory engagement and planned Phase 3 development, we believe the opportunity for a highly selective, oral FGFR3 inhibitor has never been clearer. We look forward to building on our recent momentum as we work to establish dabogratinib as a potentially transformative therapy for patients with FGFR3-driven diseases."

Third Quarter and Recent Corporate Highlights

Dabogratinib 3×3 Strategy

During the third quarter of 2026, TYRA achieved a significant milestone in its dabogratinib 3×3 strategy with initial clinical results in IR NMIBC. The strategy is focused on advancing oral dabogratinib, an investigational FGFR3-selective inhibitor, across three potentially pivotal development programs in low-grade upper tract urothelial carcinoma (LG-UTUC), low-grade IR NMIBC and achondroplasia (ACH).

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Phase 2 IR NMIBC Study – SURF302. In September 2026, TYRA reported initial results from SURF302 (data cutoff as of August 31, 2026), its Phase 2 ablative study evaluating oral dabogratinib in patients with FGFR3-altered low-grade IR NMIBC.
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At 60 mg QD, oral dabogratinib demonstrated a 79% overall response rate (ORR) and 64% best overall response (BOR) complete response (CR) rate among participants with single and multiple marker lesions (n=14).
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Among participants with a single marker lesion (n=8), 60 mg QD demonstrated a 100% ORR and 75% BOR CR rate, supporting the planned Phase 3 adjuvant strategy.

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Initial safety and tolerability results were favorable across both dose cohorts (n=44), with no clinically significant hyperphosphatemia, nail toxicity or ocular toxicity observed. There were no Grade 3 treatment-related adverse events at 60 mg QD.
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TYRA has completed enrollment in the 60 mg QD cohort and is enrolling a 70 mg QD cohort to further explore oral dabogratinib’s potential in the ablative setting.
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TYRA is advancing preparations for registrational development, including planned engagement with health authorities regarding design of a Phase 3 adjuvant study. Initiation of the study is expected in 2027, subject to regulatory feedback.
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Phase 2 LG-UTUC Study – SURF303. SURF303 is a Phase 2a/b, multicenter, open-label study designed with pivotal intent to evaluate the efficacy and safety of oral dabogratinib at two QD doses (60 mg and 80 mg) in participants with LG-UTUC. In September 2026, TYRA reported that the first participant treated in SURF303 achieved a complete response (CR) at the 3-month assessment with 60 mg QD, with no observed treatment-emergent adverse events as of the August 31, 2026 data cutoff. TYRA continues to advance enrollment and expects to report additional clinical results in 2027.
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Phase 2 ACH Study – BEACH301. BEACH301 is a Phase 2, multicenter, open-label, dose-escalation/dose-expansion study evaluating oral dabogratinib in children ages 3 to 10 with ACH. The study has advanced through five dose levels in the safety sentinel cohort. Given the favorable safety data seen to date across dose levels 1 through 5, the Data Safety Monitoring Committee authorized the opening of a sixth dose level to evaluate 0.875 mg/kg in the safety sentinel cohort. Initial results from the safety sentinel cohort, including six-month annualized height velocity and safety data, representing approximately 25 children in aggregate, are expected in 2027.

Corporate

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Completed $400 Million Financing. In September 2026, TYRA completed an underwritten public offering of common stock and pre-funded warrants with gross proceeds of approximately $400 million, before underwriting discounts, commissions and offering expenses. The financing was led by RA Capital Management, with participation from new and existing institutional investors. Together with existing cash resources, the financing is expected to support execution of the Company’s dabogratinib 3×3 strategy, as well as ongoing research and development activities, through 2030.

SNÅP Platform and Pipeline

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TYRA continued to advance its in-house precision medicine discovery engine, SNÅP, used to develop therapies in targeted oncology and genetically defined conditions.

Third Quarter Financial Results

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Cash, Cash Equivalents and Marketable Securities. As of September 30, 2026, TYRA had cash, cash equivalents and marketable securities of $700.5 million. Following its September 2026 financing, the Company expects its current financial resources to fund planned operations through 2030.
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Research and Development (R&D) Expenses. R&D expenses for the three months ended September 30, 2026 were $43.1 million compared to $25.5 million for the same period in 2025. The increase was primarily driven by dabogratinib development activities supporting the ongoing SURF303, SURF302 and BEACH301 clinical trials. The remaining increase was driven by personnel expenses, primarily due to headcount growth to support expanding clinical and development activities, and expenses for facilities and other costs.
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General and Administrative (G&A) Expenses. G&A expenses for the three months ended September 30, 2026 were $11.7 million compared to $7.5 million for the same period in 2025. The increase primarily related to higher compensation and other personnel costs, driven by headcount growth.
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Net Loss. Third quarter net loss was $51.1 million compared to $29.9 million for the same period in 2025.

Upcoming Anticipated Clinical Milestones:

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IR NMIBC: Phase 3 adjuvant study initiation; additional Phase 2 ablative study results – 2027
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LG-UTUC: Initial Phase 2 results – 2027
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ACH: Initial Phase 2 results from safety sentinel cohort – 2027
About Dabogratinib (formerly TYRA-300)

Dabogratinib is TYRA’s lead precision medicine candidate stemming from its in-house SNÅP platform. Dabogratinib is an investigational, oral, FGFR3-selective inhibitor currently in Phase 2 development for the treatment of urologic cancers and skeletal dysplasias, specifically LG-UTUC, low-grade IR NMIBC and ACH. We believe dabogratinib was the first orally available, FGFR3-selective inhibitor to enter clinical development, and it has been studied in more than 200 individuals to date across multiple clinical and healthy volunteer studies.

Oral dabogratinib is currently advancing in three Phase 2 clinical trials for LG-UTUC (SURF303), low-grade IR NMIBC (SURF302), and ACH (BEACH301). The FDA has granted Orphan Drug Designation and Rare Pediatric Disease Designation to oral dabogratinib for the treatment of achondroplasia.

Please visit the Patients page of our website for more information on our clinical trials.

(Press release, Tyra Biosciences, NOV 10, 2026, View Source [SID1234674571])